Attachment 2 - Statement of Work.docx

1.0 General

1.1 Background

The Pyxis® Medstation ES System was originally obtained under a rental agreement initiated in 2016 and has been operational in most drug storage areas in RRVAMC with a service contract to meet the Joint Commission requirements on appropriate drug storage and accountability. The current system is reaching end of life and must be upgraded to assure continuous and uninterrupted patient care at RRVAMC and remote VA clinics. System upgrade is also necessary to install previously purchased Pyxis® carousel and Pyxis® Logistics software.

1.2 Scope of Work

The automated dispensing system must continue to be an enterprise-wide system. It must continue to attach to and operate across local area networks. It must function in the main medical center, in the Substance Abuse Residential Rehabilitation Treatment Program (SARRTP) building, and at remote VA Clinics by way of one main server. This must be a scalable system, able to meet future requirements. The system must integrate with the Pyxis® carousel and Pyxis® Logistics.

Contractor shall remove and return all existing Pyxis® automated dispensing cabinets. The new system shall include upgraded cabinets to replace all existing Pyxis® equipment and expand the number of patient care areas served as required to assure adequate and secure drug storage within RRVAMC, the SARRTP, the operating rooms, and the remote VA Clinics. The current automated dispensing cabinets will be replaced at each VA clinic (Scott, Carroll, Grayson, Stonybrook, Newburg, Greenwood, New Albany, Ft. Knox), SARRTP, MPU, Cardiac Cath Lab, ED, Urgent Care, Medicine Clinic, Operating Rooms, ASU, Operating Holding Room, Dental Clinic, Pain Clinic, Radiology, Oncology Clinic, Nuclear Medicine, Procedural Areas, Med/Surg floors, and ICU. The system shall also include upgraded Pyxis® CII Safe machines for securely storing controlled substances within the pharmacies.

This machine shall continue to serve as the main ‘hub’ for storing controlled substances that will be deployed out to the various automated dispensing cabinets within the Medical Center. Pyxis® Anesthesia ES Systems will also be upgraded in each Operating Room with Codonics printers.

The system shall also provide an automated medication management system for refrigerated medications that provides controlled point-of-use access, electronically tracks and records transaction data and generates reports necessary for inventory management and regulatory compliance.

The system shall continue to provide for the pick, check, secure transportation, and delivery of medication to automated dispensing cabinets (ADCs) with tracking and closed loop documentation.

The system shall use computerized drug storage device that is designed for medication storage outside of the pharmacy that will control and track drug distribution. The system shall manage users, formulary, and bar codes for the ADCs with a single server and database.

The system shall have a reporting application that provides enterprise-wide inventory visibility and reporting for the pharmacy and patient care areas. The system shall allow unlimited concurrent users access to the system at the same time. The system shall allow management of users for all facilities from one database and users can be assigned different privileges for multiple facilities from one system. The system shall allow definition of user roles for all facilities from one database.

The system shall allow barcodes to be associated in the system one time for multiple facilities. ADCs must be able to be configured for various lengths, widths, and depths to accommodate larger items such as IV bags, propofol, etc.

Contractor is responsible for customizing cabinet and drawer configuration to meet the physical storage space and security needs of the various areas of the Medical Center. A data analytical tool that allows reporting on clinical operations, helping to identify potential diversion, ensure compliance, and monitor nursing processes such as medication administration. Reports shall be modifiable, schedulable, and able to be run at any time of the day.

The system shall have periodic software updates and upgrades at no additional charge to ensure the most up to date software and emerging technologies are available. The software shall allow nurses to remotely perform medication management tasks away from the automated dispensing cabinet at their mobile computers.

The system shall have a label printer that allows the nurse to print a patient specific label for a medication that will not be administered immediately in any setting (e.g., Operating Room and acute care floors).

The system shall be compatible with the Pyxis® Carousel Medication Technology system and the Pyxis® Logistics Inventory Management software.

Contractor shall be responsible for final disposition of existing equipment that is deemed to be the manufacturer’s property.

Contractor shall assist in setting up an internal training program for the VA as needed for pharmacy staff, nursing staff, OR staff, and the IT personnel. This shall be accomplished through the local VA Education office, in conjunction with the Contractor’s training personnel.

1.3 Period of Performance

The period of performance of this contract consists of a base period, and four (4) 12-month option periods.

1.4 Place of Performance

Pyxis® ADC point of use medication storing and dispensing devices shall be replaced at locations within the Robley Rex VA Medical Center catchment, to include Scott CBOC, Carroll CBOC, Grayson CBOC, Stonybrook CBOC, Newburg CBOC, Greenwood CBOC, New Albany CBOC, and Ft. Knox CBOC, SARRTP, MPU, Cardiac Cath Lab, ED, Urgent Care, Medicine Clinic, Operating Rooms, ASU, Operating Holding Room, Dental Clinic, Pain Clinic, Radiology, Oncology Clinic, Nuclear Medicine, Procedural Areas, Med/Surg floors, and ICU.

1.5 Applicable Documents

1.5.1 Federal Information Security Management Act of 2002, Public Law 107-347§ 208, 116 Stat. 2946 (2002)

1.5.2 Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191 § 264, 110 Stat. 1936 (2003)

1.5.3 Privacy Act of 1974, 5 U.S.C. 552a

1.5.4 15 U.S.C. §278g-3, 38 U.S.C. §5721-28, 40 U.S.C. §11331, 44 U.S.C. Chapter 35

1.5.5 OMB M-06-15, Safeguarding Personally Identifiable Information (May 22, 2006)

1.5.6 OMB M-07-11, Implementation of Commonly Accepted Security Configurations for Windows Operating Systems (March 22, 2007)

1.5.7 OMB M-07-18, Ensuring New Acquisitions Include Common Security Configurations (June 1, 2007)

1.5.8 OMB M-09-02, Information Technology Management Structure and Governance Framework (October 21, 2008)

1.5.9 National Institute of Standards and Technology: Federal Information Processing Standards (FIPS) http://scrc.nist.gov/publications/fips/index.html

1.5.10 National Institute of Standards and Technology Special Publications 800 Series http://csrc.nist.gov/publications/nistpubs/index.html

1.5.11 VAAR – 852.273-75 Security Requirements for Unclassified Information Technology Resources (Interim – October 2008)

1.5.12 VA Directive and Handbook 6500, Information Security Program

1.5.13 VA Directive 6502, VA Enterprise Privacy Program

1.5.14 VA Directive and Handbook 0710, Personnel Suitability and Security Program

1.5.15 VA Handbook 6500.1, Electronic Media Sanitization

1.5.16 VA Handbook 6500.2, Management of Security and Privacy Incidents

1.5.17 VHA Handbook 1600.01, Business Associate Agreements

1.5.18 VHA Handbook 1605.1, Privacy and Release of Information

2.0 Specific Requirements/Tasks

2.1 Network Interface

A network interface for the Pyxis® server shall be maintained in accordance with established Department of Veterans Affairs guidelines for servers with HIPAA and patient specific information. The server shall communicate successfully with all current and future associated Pyxis® devices.

2.2 Device Connectivity

All Pyxis® devices, local and remote, shall be configured and connected to the Pyxis® server.

2.2.1 Server Communication

Information Protocol (IP) addresses assigned to each Pyxis® device shall be used to connect and communicate with the Pyxis® server during the maintenance of Pyxis® devices.

2.3 Software

Pyxis® client software shall be installed and configured to permit logon and access to the Pyxis® server.

2.4 Databases

Required databases residing on the Pyxis® server shall be maintained to ensure devices remain fully functional.

3.0 Special Considerations

3.1 Contractor Responsibility

All information and data related to this project that the Contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government. The contracting officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract. Press releases, marketing material, or any other printed or electronic documentation related to this project, must not be publicized without the written approval of the contracting officer.

3.2 Government Responsibility

The Government will provide Contractor access to an intact, operational data network and server host site capable of effectively supporting day to day operation of the Pyxis® system. The Government will also furnish connectivity via computer ports for those patient care areas receiving deployed equipment and not currently having an adequate connection. Power (emergency red plug) and network receptacles for operation of the Pyxis® system will also be provided by the Government.

All Government personnel involved with the installation, configuration, and day-to-day operation of the Pyxis® system shall be properly trained on the system’s operation and current on training necessary for the protection of sensitive information while using Pyxis®.

4.0 Security Requirements

Pyxis® devices will communicate over network connections considered secure as measured against Department of Veterans Affairs National, regional, and local guidelines. The contracted maintenance requirement of the Pyxis® system will allow and require remote access to the Pyxis® System by Pyxis® technical personnel. Pyxis® will set up an account with the Department of Veterans Affairs that permits communication with the local Pyxis® System via Virtual Private Network (VPN). During specific critical situations or under circumstances considered catastrophic, communication via modem MAY be permitted by the facility ISO ONLY.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

The Contractor shall not create or maintain any records containing any non-public VHA information that are not specifically tied to or authorized by the contract.

The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

4.1 Records

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, regardless of the medium in which the record exists.

A “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Veterans Health Administration (VHA)/ VA Tennessee Valley Healthcare System (VA TVHS) records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

1. may include deliverables and documentation associated with deliverables.

Contractors, Contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

VA TVHS and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VA TVHS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA TVHS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VHA control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the contract vehicle. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The VHA/VA TVHS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this contract, and require written subcontractor acknowledgment of same.

The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (subcontractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any subcontractor) is required to abide by Government and VHA/ VA TVHS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

4.2 Access to VA Information and VA Information Systems

A Contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract.

All Contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for Contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the Contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

The Contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the Contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the Contractor or subcontractor prior to an unfriendly termination.

4.3 VA Information Custodial Language

Information made available to the Contractor or subcontractor by VA for the performance or administration of this contract or information developed by the Contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the Contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d)(1).

VA information should not be co-mingled, if possible, with any other data on the Contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the Contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of Contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

Prior to termination or completion of this contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

The Contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

The Contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on Contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the Contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

If VA determines that the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the Contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

The Contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

The Contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the Contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The Contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

Notwithstanding the provision above, the Contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the Contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that Contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the Contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

4.4 Information System Design and Development

Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

The Contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

The Contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

The Contractor/subcontractor agrees to:

a. Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

b. Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

c. Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the Contractor/subcontractor is considered to be an employee of the agency.

d. Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

e. “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

c. “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than three (3) days.

When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within ten (10) working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within one (1) day.

All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g., for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

4.5 Information System Hosting, Operation, Maintenance, or Use

For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, Contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The Contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

Outsourcing (Contractor facility, Contractor equipment or Contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the Contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) Contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

The Contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The Contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with Contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

The Contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another Contractor/subcontractor. The Contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

VA prohibits the installation and use of personally owned or Contractor/subcontractor- owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA- approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The vendor must accept the system without the drive.

4.6 Security Incident Investigation

The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The Contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/subcontractor has access.

To the extent known by the Contractor/subcontractor, the Contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the Contractor/subcontractor considers relevant.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the Contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

Antiviral software, firewall software and any other software necessary to secure uninterrupted operation and protect sensitive VA data will be applied to the medstations and servers, as is standard for all Department of Veterans Affairs workstations and servers and be compliant with national guidelines.

5.0 Additional Legal Terms

Federal law and regulations, including the Federal Acquisition Regulations (“FAR”), shall govern this Order. Commercial license agreements may be made a part of this order but only if both parties expressly make them an addendum. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap) or any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Order.; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of stat shall not be included or made a part of this order. Federal law and regulation, including without limitation, the Contract Disputes Act (41 U.S.C. §601-613), the Anti-Deficiency Act (31 U.S.C. §1341 et seq.), the Competition in Contracting Act (41 U.S.C. §2304), the Prompt Payment Act (31 U.S.C. §3901, et seq.) and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control and render ineffective any inconsistent, conflicting or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ). 28 U.S.C. § 516. At the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Order must be made by order modification (Standard Form 30). Nothing in this Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.